Wearable tACS brain stimulation for anxiety in Veterans
Transcranial Alternating Current Stimulation (tACS) for the Treatment of Anxiety in Veterans: An Open-Label Pilot Study
This will test whether a wearable tACS (low-intensity alternating current) device can reduce anxiety in Veterans with at least moderate symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 19 Years to 70 Years |
| Sex | All |
| Sponsor | Birmingham VA Health Care System Federal |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT07288008 on ClinicalTrials.gov |
What this trial studies
This open-label pilot will enroll up to 40 Veterans age 70 or younger with clinically significant anxiety to use a wearable tACS device (Fisher Wallace FW-200) over 8 weeks. After an in-person orientation and training session at the Birmingham VA, participants will self-administer low-intensity alternating current at home and may remain on stable antidepressant doses. The trial will measure feasibility, acceptability, adherence, and changes in anxiety, depression, PTSD symptoms, sleep, and neurocognitive outcomes. Previous sham-controlled trials have suggested tACS is rapid-acting and well tolerated, but additional data are needed specifically in Veteran populations.
Who should consider this trial
Good fit: Ideal candidates are English-speaking U.S. military Veterans aged 18–70 with clinically significant anxiety (GAD-7 ≥10) who can attend an in-person training visit and, if applicable, are on stable antidepressant doses.
Not a fit: Patients with bipolar I, schizophrenia spectrum or other psychotic disorders, recent moderate-to-severe substance use disorder, a history of severe traumatic brain injury, those over age 70, or non-Veterans are unlikely to be eligible or benefit.
Why it matters
Potential benefit: If successful, the device could provide Veterans a convenient, at-home, non-drug option to reduce anxiety and related symptoms.
How similar studies have performed: Prior sham-controlled trials in non-Veteran populations have reported therapeutic effects and good tolerability of tACS for anxiety and depression, though evidence in Veterans and for PTSD/neurocognitive outcomes is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veteran of the U.S. military * English-speaking and provides signed informed consent and HIPAA * Adults ≤70 years of age * Past week's GAD-7 of ≥10 which represents at least moderate level of anxiety * If applicable, antidepressants may be continued if taking the concomitant medication for ≥8 weeks and at stable doses for ≥4 weeks * Participants of child-bearing potential must have negative pregnancy test at entry and must agree to adhere to a medically acceptable method of birth control Exclusion Criteria: * Lifetime bipolar type I, schizophrenia spectrum, or other psychotic disorders based on VA medical records * Current sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within the past 6 months based on VA medical records and clinical interview * Diagnosis of moderate to severe alcohol and/or cannabis use disorder within past 6 months based on VA medical records and clinical interview * History of severe traumatic brain injury (TBI), defined by Ohio State University TBI Identification Method * Dementia or related progressive neurocognitive disorder as per the medical record * Use of prohibited medications (see list above) in the prior 2 weeks * Increased risk of suicide that necessitates inpatient treatment, suicidal ideation/behavior endorsed on 6-item Columbia Suicide Severity Rating Scale screening questionnaire (yes" to question 4 or 5; or yes to # 6 as current), and/or suicidal behavior within past 90 days. * Treatment with electroconvulsive therapy, vagus nerve stimulation, or transcranial magnetic stimulation within the past 6 months * Implanted central nervous system devices (e.g. deep brain stimulation) * Implanted cardiac pacemaker * Trigeminal neuralgia that is currently symptomatic * Treatment with evidence-based psychotherapy (EBP) for anxiety, depression or PTSD in the past 14 days. If receiving EBP therapy, he/she should complete EBP prior to entering study. Veterans currently engaged in non-EBP, e.g., supportive counseling or skills group therapies, may continue in these if they have been in this treatment for at least 4 weeks prior to baseline assessments. * Pregnancy during treatment * Clinically significant medical/surgical illness that would contraindicate use of tACS, e.g. unstable cardiac condition, those who fear electrical stimulation, presence of skin irritation or abrasions around either electrode site, or who have shrapnel fragments near either electrode site. * Litigating for disability income for a mental disorder outside the VA compensation and pension process
Where this trial is running
Birmingham, Alabama
- Birmingham VA — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Lori Davis, MD — Birmingham VA Health Care System
- Study coordinator: Lori L Davis, MD
- Email: lori.davis@va.gov
- Phone: 205-933-8101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.